FFR-Guided Revascularization Study

Sweden: Fractional flow reserve (FFR)-guided complete revascularization does not result in better outcomes compared with primary percutaneous coronary intervention (PCI) of the culprit lesion among patients with STEMI or very-high-risk NSTEMI and multivessel coronary artery disease, randomized FULL REVASC trial has shown.

"At a median follow-up of 4.8 years, a primary outcome event -- myocardial infarction, death from any cause, or unplanned revascularization -- occurred in 19% of patients in the complete-revascularization group versus 20.4% of those in the culprit-lesion-only group (HR 0.93)," the researchers reported during the American College of Cardiology annual meeting. The findings were subsequently published in The New England Journal of Medicine.

Also, there were no differences in the composite of death from any cause or myocardial infarction between the complete-revascularization group and the culprit-lesion-only group (16.5% vs 15.3%; HR 1.12) or unplanned revascularization (9.2% vs 11.7%; HR 0.76).

When a patient presents with myocardial infarction, the urgency to restore blood flow to the affected area is paramount. PCI has long been the standard of care, but the debate continues between complete revascularization and culprit-only intervention. FFR has emerged as a valuable tool in guiding this decision-making process, offering insights into the hemodynamic significance of coronary lesions.

Against the above background, Felix Böhm, the Karolinska Institutet and Danderyd Hospital in Sweden, and colleagues explored the role of FFR guidance in determining whether complete or culprit-only PCI is more appropriate for patients with MI.

For this purpose, the researchers conducted a multinational, registry-based, randomized trial, including patients with STEMI or very-high-risk non-STEMI (NSTEMI) and multivessel disease undergoing primary PCI of the culprit lesion. A total of 1542 patients underwent randomization, 764 were assigned to receive FFR-guided complete revascularization, and 778 were assigned to receive culprit-lesion-only PCI.

The two key secondary outcomes were a composite of death from any cause or myocardial infarction and unplanned revascularization.

Key Findings of the Study

• At a median follow-up of 4.8 years, a primary-outcome event had occurred in 19.0% of patients in the complete-revascularization group and in 20.4% in the culprit-lesion-only group (hazard ratio, 0.93).
• For the secondary outcomes, the researchers observed no apparent between-group differences in the composite of death from any cause or myocardial infarction (hazard ratio, 1.12) or unplanned revascularization (hazard ratio, 0.76).
• There were no apparent between-group differences in safety outcomes.

In conclusion, among patients with STEMI or very-high-risk NSTEMI and multivessel coronary artery disease, FFR-guided complete revascularization did not result in a lower risk of a composite of death from any cause, myocardial infarction or unplanned revascularization than culprit-lesion-only PCI at 4.8 years.

The study's main limitation was that it had to be terminated early for feasibility and ethical reasons, which resulted in a long duration of follow-up for enough events to accrue.

Reference

Böhm F, Mogensen B, Engstrøm T, Stankovic G, Srdanovic I, Lønborg J, Zwackman S, Hamid M, Kellerth T, Lauermann J, Kajander OA, Andersson J, Linder R, Angerås O, Renlund H, Ērglis A, Menon M, Schultz C, Laine M, Held C, Rück A, Östlund O, James S; FULL REVASC Trial Investigators. FFR-Guided Complete or Culprit-Only PCI in Patients with Myocardial Infarction. N Engl J Med. 2024 Apr 8. doi: 10.1056/NEJMoa2314149. Epub ahead of print. PMID: 38587995.